Cleaning Validation Technologies

Destin A. LeBlanc-Technical Consulting Services

BASIC CONCEPTS IN CLEANING AND CLEANING VALIDATION


Course Instructor: Destin A. LeBlanc

Course Length: Two full days

Summary: This course is designed to comprehensively cover basic issues in cleaning processes for pharmaceutical manufacturing equipment and the validation of those cleaning processes. It begins with cleaning objectives, moves into the design of cleaning processes, and then covers basic cleaning validation issues.

Target Audience: This training is designed for professionals engaged in the design, execution, and validation of cleaning processes. This includes validation scientists, analytical chemists, microbiologists, QA/QC scientists, production engineers, toxicologists, regulatory specialists, and their managers.

Format: This training primarily is in a lecture format, but includes two small group exercises. Interaction and questions are encouraged to facilitate understanding.

Course Outline: Section 1: Cleaning objectives

Section 2: Overview of Validation Programs

Section 3: Regulatory Issues

Section 4: Cleaning Technologies

Section 5: Engineering Issues

Section 6: Cleaning SOPs

Section 7: Residues and Limits

Section 8: Analysis and Sampling

Section 9: Microbial Control Issues

Section 10: Validation Protocols

Section 11: Validation Strategies

Section 12: Validation Maintenance

Customization: Subjects can be expanded, shortened, and/or appropriately modified to fit your training objectives.

Fees: The fee for the standard two-day course is $10,000 plus travel expenses. If the course is shortened to a one-day presentation, the fee is $7,500 plus travel expenses. In either case, the client provides the training facility with a video projector and a writing board/flip chart. This fee includes all training materials and certificates of completion. Cleaning Validation Technologies will send the client a pdf file of the training materials for photocopying and assembling into training booklets by the client.